MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC MONOJECET; MONOJECT BLUNT FILL NEEDLE 18G*1 1/2"

Model Number	11811022
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report was initially submitted on 01/24/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
The customer reported that they have been using a substitute needle to draw up drugs in anesthesia while their primary blunt tip syringe is on backorder.One of their crnas had two instances where the bluntfill needle cored the vial top and sucked the piece of plastic core into the syringe.If he hadn't caught this it would have then been injected into a patient.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.Our evaluation of the risk, which follows guidance from iso 14971, indicates that the overall risk for the reported failure is low.This evaluation is based on our track and trend analysis and risk management files which are evaluated and updated constantly based on post market surveillance.Due to unavailability of batch number, the investigation couldn't able to conclude.As part of our continued commitment to our customers, sol millennium will continue to monitor the complaints trend for the reported failure mode and take any corrective action based on our procedures, if a significant pattern emerges.Scar 20241001 was initiated at the manufacturing site to track the investigation and application of corrective actions associated with the event.Corrective actions include optimization of sandblasting process and equipment, increase inspection sampling frequency, and update engineering drawings to clarify sandblasting requirements.Corrective actions were verified by inspection of 3 batchs produced after improvement implementation.This supplemental mdr is being submitted to correct the brand name provided in the initial mdr [3014312726-2025-00011].The previously reported brand name was incorrect.The correct brand name is monoject.

• Brand Name: MONOJECET
• Common Device Name: MONOJECT BLUNT FILL NEEDLE 18G*1 1/2"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr; suite 4100; chicago
• MDR Report Key: 22035620
• Report Number: 3014312726-2025-00011
• Device Sequence Number: 21029701
• Product Code: GAA
• UDI-Device Identifier: 10884521544826
• UDI-Public: (01)10884521544826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11811022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown